Type II DiabetesNCT00985114
Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity
A study testing EndoBarrier and Diet + Lifestyle Counseling in people with Type II Diabetes, run by Morphic Medical Inc. at 3 sites in Netherlands.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a second generation EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes. This is a randomized, controlled study which will enroll approximately 70 Subjects with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- EndoBarrier and Diet + Lifestyle Counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 3 sitesNetherlands
- Study dates
- Oct 2009to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 65 years
- Male or Female
- Subjects with Type 2 Diabetes who have been treated for ≤10 years
- BMI> 30 - < 50
- Subjects with an HbA1c level > 7.5 and ≤ 10.0%
- Subjects taking a combination of metformin and sulfonylureas and/or insulin (other than pre-mixed long and short acting insulins, ie. NovoMix 30)
- Patients willing to comply with study requirements
- Patients who have signed an informed consent form
Who cannot join
- Subjects taking oral medications to control their diabetes other than sulfonylureas and metformin
- Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- Subjects on insulin > 10 years
- Subjects requiring insulin > 70 units per day
- Subjects on pre-mixed insulin (ie. NovoMix 30)
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Ziekenhuis Rijnstate Arnhem
Arnhem
Medisch Centrum Parkstad
Heerlen
University Hospital Maastricht
Maastricht
About this study
Official title: An Open Label, Randomized, Controlled Study of a Second Generation EndoBarrier™ Liner vs. Diet Control for the Treatment of Type 2 Diabetes
The purpose of this study is to evaluate the safety and efficacy of a second generation EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.
This is a randomized, controlled study which will enroll approximately 70 Subjects with Type 2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will be offered the EndoBarrier device after 12 months on study at the investigator's discretion if treatment of the device subjects indicates adequate efficacy. This study will be conducted at three (3) investigational sites.
Read more
The primary efficacy endpoint is:
- Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24 weeks or last visit from baseline between the two groups.
Secondary endpoints are:
- Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit from baseline.
- Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or discontinued at week 24 or last visit from baseline.
- Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from baseline.
- Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.
- Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12 months.
- Compare physical component summary (PCS), mental component summary (MCS) and quality adjusted life years (QALYs)via analysis of the SF-36v2 QOL.
Read the detailed description
Utilization of the EndoBarrier Gastrointestinal Liner in obese subjects with T2DM demonstrated an acceptable safety profile with clinically significant improvements in glycemic control and body weight when compared to a similar diet controlled group of subjects.
- Conditions
- Type II Diabetes
- Being tested
- EndoBarrier, Diet + Lifestyle Counseling
- Keywords
- Type II Diabetes, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoBarrierDevice
EndoBarrier implant
Diet + Lifestyle CounselingBehavioural
Multidisciplinary lifestyle and nutritional counseling
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | EndoBarrier implanted for 6 months. Subject followed for 6 months after device was explanted. Receives: Device: EndoBarrier; Behavioral: Diet + Lifestyle Counseling |
| Diet + Lifestyle counseling | Active comparator | Multidisciplinary lifestyle and nutritional counseling for 12 months Receives: Behavioral: Diet + Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Willem Greve, MD, Principal investigator, University Hospital Masstricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985114
- Sponsor's protocol ID
- 07-1
- Status last verified
- Aug 2016
- First submitted
- 25 Sep 2009
- Last updated
- 3 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Yes De-identified individual subject data is on file at the Sponsor
Publications
de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Bouvy ND, Greve JW. Impact of Duodenal-Jejunal Exclusion on Satiety Hormones. Obes Surg. 2016 Mar;26(3):672-8. doi: 10.1007/s11695-015-1889-y.
PubMed 26446491Koehestanie P, de Jonge C, Berends FJ, Janssen IM, Bouvy ND, Greve JW. The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Ann Surg. 2014 Dec;260(6):984-92. doi: 10.1097/SLA.0000000000000794.
PubMed 25072436de Jonge C, Rensen SS, Koek GH, Joosten MF, Buurman WA, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves plasma parameters of nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1517-20. doi: 10.1016/j.cgh.2013.07.029. Epub 2013 Aug 3.
PubMed 23920034
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Controlled Study of a Second Generation EndoBarrier™ Liner vs. Diet Control for the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00985114
- Acronym / sponsor ID
- 07-1
- Conditions
- Type II Diabetes
- Keywords
- Type II Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Posted 3 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of a second generation EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.
This is a randomized, controlled study which will enroll approximately 70 Subjects with Type 2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will be offered the EndoBarrier device after 12 months on study at the investigator's discretion if treatment of the device subjects indicates adequate efficacy. This study will be conducted at three (3) investigational sites.
The primary efficacy endpoint is:
- Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24 weeks or last visit from baseline between the two groups.
Secondary endpoints are:
- Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit from baseline.
- Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or discontinued at week 24 or last visit from baseline.
- Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from baseline.
- Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.
- Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12 months.
- Compare physical component summary (PCS), mental component summary (MCS) and quality adjusted life years (QALYs)via analysis of the SF-36v2 QOL.
Detailed description
Utilization of the EndoBarrier Gastrointestinal Liner in obese subjects with T2DM demonstrated an acceptable safety profile with clinically significant improvements in glycemic control and body weight when compared to a similar diet controlled group of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: EndoBarrier, Behavioral: Diet + Lifestyle CounselingEndoBarrier implanted for 6 months. Subject followed for 6 months after device was explanted. |
| Diet + Lifestyle counseling | Active comparator | Behavioral: Diet + Lifestyle CounselingMultidisciplinary lifestyle and nutritional counseling for 12 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years and < 65 years
- Male or Female
- Subjects with Type 2 Diabetes who have been treated for ≤10 years
- BMI> 30 - < 50
- Subjects with an HbA1c level > 7.5 and ≤ 10.0%
Key exclusion criteria (5 listed)
- Subjects taking oral medications to control their diabetes other than sulfonylureas and metformin
- Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- Subjects on insulin > 10 years
- Subjects requiring insulin > 70 units per day
- Subjects on pre-mixed insulin (ie. NovoMix 30)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoBarrierEndoBarrier implant | Device | Device |
| Diet + Lifestyle CounselingMultidisciplinary lifestyle and nutritional counseling | Behavioural | Device, Diet + Lifestyle counseling |
Primary outcome
Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26446491de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Bouvy ND, Greve JW. Impact of Duodenal-Jejunal Exclusion on Satiety Hormones. Obes Surg. 2016 Mar;26(3):672-8. doi: 10.1007/s11695-015-1889-y.
- Derived from this study: PubMed 25072436Koehestanie P, de Jonge C, Berends FJ, Janssen IM, Bouvy ND, Greve JW. The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Ann Surg. 2014 Dec;260(6):984-92. doi: 10.1097/SLA.0000000000000794.
- Derived from this study: PubMed 23920034de Jonge C, Rensen SS, Koek GH, Joosten MF, Buurman WA, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves plasma parameters of nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1517-20. doi: 10.1016/j.cgh.2013.07.029. Epub 2013 Aug 3.
- Individual participant dataSharing planned: Undecided. Yes De-identified individual subject data is on file at the Sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Willem Greve, MD principal investigator
University Hospital Masstricht
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoBarrier and Diet + Lifestyle Counseling in people with Type II Diabetes, run by Morphic Medical Inc. at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00985114, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.